Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD) (www.biomoda.com) and Obio, a corporation formed to pursue public and private funding for cancer research in Ohio, signed a memorandum of understanding (MOU) to establish a CLIA-certified Biomoda clinical laboratory in Ohio to support ongoing research and development on Biomoda's porphyrin-based assay for the detection of early-stage cancer.
“Ohio is proactively attracting promising biotech companies to the state through public initiatives that support research and commercialization. This fits perfectly with our strategic plan for taking CyPath® into the marketplace.”
The Clinical Laboratory Improvement Amendments (CLIA) were passed by Congress in 1988 to establish standards for laboratory testing and ensure the accuracy and reliability of patient test results. Laboratories that meet CLIA standards are certified by the U.S. Department of Health and Human Services.
"We are ready to expand our strategic alliance with Obio to include operational facilities that will put us in closer contact with Ohio's top-rated medical, scientific and technical resources," said Biomoda President John Cousins. "Ohio is proactively attracting promising biotech companies to the state through public initiatives that support research and commercialization. This fits perfectly with our strategic plan for taking CyPath® into the marketplace."
Biomoda currently is conducting clinical trials of its CyPath® labeling solution, an inexpensive, noninvasive assay designed to identify early-stage lung cancer by binding to cancer cells and causing them to fluoresce under ultraviolet light. Biomoda is seeking Food and Drug Administration (FDA) approval of its screening technology as a Class III medical device. CyPath® is currently for investigational use only.
Initially, the lab formed in partnership between Biomoda and Obio could employ up to 12 trained technicians to prepare fluid and tissue samples for immersion into the CyPath® labeling solution and subsequent screening under an ultraviolet microscope. Pending FDA approval, widespread commercialization of the CyPath® product would require significant expansion of the lab facility, creating additional jobs and a positive impact on Ohio's economy.
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